510(k) K200530 ยท GKT Separator, Automated, Blood Cell, Diagnostic
AMICUS Separator System
| Applicant | Fresenius Kabi AG, Lake Zurich IL, US |
| Decision | Substantially Equivalent, Sep 11, 2020 |
| Received | Mar 2, 2020 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K200530
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.